Market Access Opportunities for Novel Therapies Targeting Multi-Drug-Resistant Pathogens Hospital-treated Gram-negative infections (GNIs) are becoming increasingly difficult to treat given rising rates of infections caused by multi-drug resistant (MDR) pathogens. As a result, many GNIs can no longer be effectively treated with antibiotics previously considered to be the most potent agents (i.e., third-generation cephalosporins, fluoroquinolones, and carbapenems). Therefore, commercial opportunities exist for new agents that can help address the threat of drug-resistant Gram-negative pathogens (GNPs). Notably, emerging broad-spectrum antibiotics such as Merck’s Zerbaxa (ceftolozane/tazobactam) and Allergan/AstraZeneca’s Avycaz (ceftazidime/avibactam) will provide therapeutic options for many of these difficult-to-treat infections, including those caused by extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae and carbapenem-resistant GNPs. However, in highly cost-sensitive markets such as those found in the EU5, marketers of novel antibiotics will need to provide clear evidence of clinical improvements and/or cost benefits over well-entrenched, generically available standard-of-care agents, to receive a favorable health technology assessment (HTA) and command premium pricing.

Questions Answered in This Report:

  • Demonstrating improvements over currently available GNI agents will be key during reimbursement and pricing negotiations. What attributes must an emerging therapy possess to secure a favorable HTA review at national and/or regional levels in each of the EU5 markets? What types of extra-funding mechanisms are available as a supplement for the reimbursement of novel GNI therapies with high price premiums? How do country-specific cost-containment measure impact uptake of current GNI antibiotics and how will they impact uptake of emerging agents?

  • The inclusion and positioning of GNI antibiotics in the hospital formulary will be the primary driver of market access in the hospital-treated GNI market. Which currently marketed antibiotics for GNIs have achieved favorable positioning within regional/hospital formularies? What are the key drivers and constraints of formulary inclusion for GNI antibiotics? What are the most convincing and influential drug attributes considered during the regional/hospital P&T committees’ decision-making process?

  • The hospital-treated GNI market is dominated by generics given that most infections can be treated effectively with older agents. What are the most prescribed and preferred antibiotics for the treatment of GNIs, including infections caused by drug-resistant pathogens (e.g., carbapenem-resistant Enterobacteriaceae and MDR Acinetobacter spp.)? What are the key drug attributes that drive or constrain physician prescribing? What do physicians and payers consider to be the major unmet needs in the treatment of GNIs? What impact will emerging therapies such as ceftolozane/tazobactam and ceftazidime/avibactam have on the treatment of GNIs?

  • Newly approved antibiotics are typically reserved for later lines of therapy, both as a cost-containment measure and a way to stave off emergence of drug resistance. How have payer policies impacted the uptake of key GNI agents? What types of prescribing restrictions do current antibiotics have? How have these restrictions impacted the use of recently-launched GNI antibiotics by prescribing physicians? What is the impact of antimicrobial stewardship programs on the prescribing of GNI antibiotics?

Scope:

This European Physician & Payer Forum report titled Gram-Negative Infections in the Cost-Constrained EU5: Market Access Opportunities for Novel Therapies Targeting Multi-Drug-Resistant Pathogens explores stakeholder perspectives that affect uptake and sales of key branded antibiotics for hospital-treated infections due to drug-resistant GNPs, and dynamics that will promote or restrict market access and uptake of emerging therapies to treat these infections in EU5 hospitals.

Markets covered: France, Germany, Italy, Spain, and the United Kingdom.

Primary research: Online survey of 252 internal medicine physicians and ID specialists and 15 country-specific interviews with payers, as follows:
- France: Physician coordinator of transparency committee, HAS advisors, ex-member of CEEPS committee
- Germany: G-BA advisor, hospital pharmacy director, ex-member of G-BA &aamp; BfArM committee member
- Italy: AIFA, CTS, and CPR member, AIFA advisor/ex-AIFA and CTS member, hospital/regional pharmacy director
- Spain: Hospital/regional formulary committee members, hospital/regional pharmacy directors
- United Kingdom: Regional formulary committee advisor/chief pharmacist, regional/hospital formulary committee members

Author(s): Jiamin Zhuo, Ph.D.